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My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses.

These numbers are way beyond the predictions of most researchers and policy makers for stem cell clinics in the U.S., and point to a burgeoning, huge industry from coast to coast (see map below of clinic locations that we found in our research that is Figure 1 of the paper).

We focused on those businesses that as best as we could determine do not have FDA approval for marketing stem cell treatments. This means that even if relatively few patients are seen at each of the 570 locations, tens of thousands of Americans each year may be getting stem cell offerings that do not have formal FDA approval.

The businesses in general market fat, bone marrow, and amniotic-related stem cells for a surprisingly wide range of conditions too, pretty much from head to toe and A to Z in a medical dictionary of conditions. It’s not clear scientifically if there are data to concretely support the use of these types of stem cells for such a wide spectrum of conditions.

Our goal was to document this direct-to-consumer marketed industry as fully as possible even as we excluded those businesses that had INDs or operated outside the U.S. A challenge in that regard is that the FDA keeps information about INDs private.

Importantly on the other hand some businesses while having no formal FDA approval may still be compliant because they fall within specific categories of usage. For instance, in some cases with a subset of these clinics such as those that use largely unmodified bone marrow cells for autologous use in homologous orthopedic conditions, no FDA “drug” approval is likely needed.

However, in many other kinds of treatment scenarios that we documented there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

Still, I do not condone the use of words like “non-compliant” or “shady” to describe all at once this entire clinic marketplace or to characterize the full list of businesses in our database because of a number of reasons including the issue mentioned above with bone marrow being used in a homologous way in some cases as well as the overall complexity of this arena and the lack of clarity from the FDA.

I’ll have more to say about the paper, but I hope you find it a valuable resource.

Sounds like the FDA has 570 problems ???? or could these clinic be opportunities to move stem cell science……Just maybe the drug process does not fit the regenerative cellular process …… Need standards for potency , migration , antigen presentation and cytokine expression in microbiome

Amazing! That may partially explain the extended FDA comment period and push out of the hearings. Big money talks in this country and a ton of it is likely flowing through these clinics. However, what does the fact that while all these clinics are operating there have been so few news stories of patients being harmed mean? I’d bet that 95+% use adult autologous stem cells.

@WST – Certainly regarding autologous treatments, which comprise the vast majority, it’s because only a handful of patients have been harmed or else many are being harmed who don’t report it to anyone. Which is more likely to be true, especially when you consider how much press coverage every “stem cell treatment gone bad” story gets? There’s easily been 100,000 people treated in the US over the past 5 years and yet, there’s only a few stories about anyone being harmed. …”but it might cause cancer” Hmmmmm…..

With a clause discharging the clinic, stipulating that the “treatment receiver” is solely responsible of whatever serious AE the treatment may cause, the patients may simply feel unable to initiate a court action.
The situation shows a major flaw in the US federal legal framework on the matter, and the outlook from situation at this stage says it would be extremely difficult to stop such proliferation unless the federal gov’t, ethic committee and a scientific EWG work TOGETHER, without entering in a sophism of a philosophical debate. The problem is here and now.

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